Phase 2 Trial Evaluating Different Doses of HUC1-394 Eye Drops for Adults with Moderate to Severe Dry Eye Disease

What this Trial Is About

Researchers are studying different dosing schedules of HUC1-394 eye drops in adults with moderate to severe dry eye disease. This phase 2 clinical trial aims to find the best dose by evaluating how effective and safe the treatment is when given at various frequencies. The goal is to improve symptoms for people who have experienced dry eye disease for at least three months. Participants will be randomly assigned to receive either HUC1-394 eye drops twice or three times daily, or a placebo eye drop. Each dose involves instilling one drop in each eye. The study compares these groups over a 12-week period to see which dosing schedule works best. The treatment phase involves regular use of the assigned eye drops, with careful monitoring by the study team. During the study, participants will undergo eye examinations including measuring the total corneal staining score using the National Eye Institute scale at the start and after 12 weeks. Other assessments include the Schirmer test, tear break-up time, and symptom questionnaires. Safety and adherence to the treatment will be monitored throughout the trial, which spans from screening through 12 weeks of treatment.

Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease